| A beneficiary from the runaway success of the Indian BPO industry is the CRO community. Why is clinical research on the rise, and what is the future for the Indian CRO industry? Deepali Gupta explores. |
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 Currently pegged at close to $100 million, the Indian CRO market, in an optimistic estimate, is likely to grow three-fold in a span of just five years. As Contract Research and Manufacturing Services (CRAMS) has been a lucrative and ever growing industry around the world, recent years have seen a major outsourcing of these services to India. The reason is simple. India is still riding the outsourcing wave.
The boom in outsourced services for IT earned a reputation for Indian firms in international circles. It established a credibility and comfort level for MNCs to offshore some of their non-core yet vital tasks to India. Time proved that Indians are capable of handling latest technology and providing world-class services. It also confirmed the fact that Indian firms are capable of rising to the occasion and establishing appropriate infrastructure, particularly IT, when required. |
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| Reason for the CRO boom |
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 As new drug pipelines of the large pharma companies begin to dry up, it has become critical for organisations to try permutations and combinations to increase the product lifecycle of existing products. "This presents an opportunity for Indian CROs to provide innovative studies for old and existing molecules as well as cocktail drugs," says Nailesh Bhatt, Managing Director, Proximare.
In addition, numerous products have gone off patent, post GATT and ANDAs for the drugs have correspondingly been on the rise. That spells good news for the Indian CRO industry, because it implies that more companies are seeking to conduct studies to prove the effectiveness of slightly modified treatments that have proved successful in the past. "The drying pipelines won't have a major impact on the clinical trials industry. On the contrary the industry is bound to grow," says Dr Mary Francis, CEO, Ace Biomed. |
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 Besides, the big pharmacos who are running out of new products, are being replaced by smaller biotech companies that are trying variations of treatments leading to further clinical research. "Stem cell therapeutics, monoclonal antibodies and rDNA products are expected to overtake traditional therapies," explains Dr Ramanand Nadig, Chief Operating Officer, Manipal Acunova.
An increased amount of activity in clinical trials has also been observed due to more firms in alternative medicine, such as Ayurveda and homeopathy, entering trials to scientifically prove the efficacy of their treatments vis-à-vis allopathic medication. |
| What services |
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| The CRO industry provides multiple services to pharma companies. As Bhatt observes, buyers today are looking for a one-stop shop. Formerly, the focus of clinical research conducted in India was primarily bioavailability and bio-equivalence studies. In the recent past, CROs have expanded their portfolios to include pre-clinical trials, Phase I-IV trials, data management and site management. |
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 In addition to the entire suite of services, Indian CROs have foundinnovative ways to provide value-adds, primarily by helping in study design, and reducing time and cost of studies. That is possible because Indian CROs are comfortable with using innovative technology to manage the processes in error-free ways.
Manipal Acunova conducts clinical trials for several Indian and multinational firms. Right now, says Nadig, the CRO provides for Phase II and III trials for international clients, and Phase I and II for Indian organisations. The key therapeutic areas currently include oncology, psychiatry, neurology, endocrinology, cardiovascular, stem cell and radiology and devices. |
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 Schedule Y restricts CROs from testing new chemical entities discovered overseas, which is why Phase I trials are only meant for Indian clients. However, Indian clients only have a limited number of Phase III and Phase IV trials, perhaps because the upcoming research community is yet to reach that stage. "We can surely provide Phase III and IV studies to our Indian clients, but the current break-up is such that most Indian clients are doing Phase I and II, and the international ones need Phase II and III," explains Nadig. |
| Advantage India |
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Apart from the BPO wave, India has many benefits to offer organisations seeking to outsource clinical research services to India. The foremost is the fluency in English, and therefore the ease with which we adopt documentation and communication processes. The next most crucial factor in India's favour is the cost advantage. While McKinsey studies suggest that clinical research in India is one-fourth the cost of research in developed markets, a more conservative estimate from Ernst & Young suggests that Phase II and Phase III trials in India are 60 percent cheaper than in Europe or America.
Other advantages include: patient diversity and heterogeneity; familiarity with western medical facilities and proficiency in allopathic medical practice; cost efficiency; reduced timelines and easy patient recruitment; internationally certified centralised lab facilities; project management competencies and a dedicated follow through to complete tasks; and amenable yet confidence-inspiring regulations.
Indeed, the ICH-GCP guidelines, critical for reliable clinical research, have been mandated in India, unlike the rest of the world. "Indian regulatory authorities (DCGI, ICMR) have issued the Indian version of GCP which is in compliance with ICH-GCP. India is the only country which has made GCP a regulation for conduct of clinical trials whereas it is a guideline in the rest of the world," explains Nadig. To the credit of the government, the TRIPs agreement protects organisations from patent infringement, and that has further aided the boost to the Indian CRO sector. |
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| Profiling the patient |
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Clinical research is one industry that actually stands to benefit from the population explosion in India. The multicultural environment in India accounts for a diverse patient population in terms of both lifestyle and genetic make up, in research. The large numbers enable CROs here to hire a large sample size of patients that fits into the required profile.
The other advantage of Indian patients for clinical trials is that the healthcare culture here is still conservative. Therefore, unlike a large section of the population in developed markets, people cannot afford and consciously avoid self-medication for every little problem. This means that the drugs administered during trials will usually not interfere with other medicines, and the systems of the patients will react ab initio, rather than displaying suspect symptoms. |
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| Trouble at hand |
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The Indian CRO industry has a lot going for it. Nevertheless, it is not entirely problem-free. Many have raised ethical alerts in the recruitment process of Indian patients. Often the patients are uneducated, or only partly educated. It has been argued that these people do not know what they are getting into when enrolling for a trial. Giving them money for these studies may be treated as coercion.
The converse of course is that these are poor people who cannot afford treatment. In the normal course, they would suffer, eventually be incapable of working and become a liability to their families. At least this way they continue to earn, and will possibly be cured. The approval process to clear clinical trials and initiate action still takes longer in India than elsewhere. Several members in the community are distressed as the government takes up to 90 days to clear studies. While the government has been trying to reduce the time, it is also important to remember that health matters are sensitive, and any such path has to be tread carefully.
A more recent concern in the industry is that of qualified staff. As the industry flourishes, there is a need for a workforce that is not only qualified on paper, but also effective in practice. Francis admits freely, that currently, "There is a dearth of quality personnel in this industry."
In fact, it is crucial for the CRO community to be perceived as one that can deliver as much as the certificates promise. "More than paper standards, it is the overall belief, SOPs, and attitude of the company that enable a company to win global contracts. Parameters that are required include good management, financial strength, technical capabilities and infrastructure," says Bhatt.
Despite being one of the few countries that mandates ICH-GCP practice for clinical trials, there are other country-specific regulations such as 21 CFR Part 11 for the US, that outsourcing partners will have to be conscious of and compliant with. |
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| Here to stay |
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| At present, Nadig estimates, "India has been contributing to 10-15 percent of the patient population in clinical trials, but it's likely that India and China will occupy the prime place contributing to over 50 percent in the near future." As such, the trend to outsource is here to stay, driven by economics. However, India must ensure a competitive edge over China and competitors from Eastern Europe, because the language barrier in other countries will be bridged sooner rather than later. Then the quality would speak for itself. Until then the Indian CROs have to tread the fine line of maintaining low cost and high quality. |
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